Nitrite screening in the Pharmaceutical Industry: The Power of the ATNA System
Jul 25 2023
In the world of pharmaceutical manufacturing and quality assurance, nitrites have been identified as a considerable concern. With the requirements to complete risk assessments for product lines for the risk of nitrosamine contamination. These chemical compounds have been identified as having the potential to form nitrosamines during the drug manufacturing process, interacting with amines in active pharmaceutical ingredients (APIs). Given the potential health implications of nitrosamines, including carcinogenic properties, understanding nitrite content is now a crucial part of the risk assessment process to ensuring the safety of pharmaceutical products.
The Ellutia Automated Total Nitrosamine Analyser (ATNA) is most commonly used for screening for total nitrosamine content. However the ATNA also offers a new solution for rapidly screening nitrite content, thereby providing significant advancements in risk assessment and new product development processes.
The ATNA consists of the Ellutia 800 series Thermal Energy Analyser (TEA), a headspace autosampler with a vortex mixer, heated agitator, custom TEA inlet and sample trays. Up to 120 samples, blanks and standards can be mounted on the sampler, for 12 hours of unattended analyses.
The ATNA system operates in two stages. Initially, nitrosamines and nitrites are reduced by hydrobromic acid, releasing nitric oxide (NO) into the headspace of the reaction vial. This is then sampled and injected into the TEA detector where subsequently, the NO reacts with ozone to produce an energetic form of nitrogen dioxide (NO2), which releases a photon of light for measurement. The system is able to detect down to low ppb levels.
One challenge presented is the system only gives a single response for all nitrosamine and nitrite content present. Whilst this is a useful results in itself, it is clearly beneficial to be able to differentiate between if the signal is generated by nitrosamine or nitrite content. A SPE Cartridge has been developed by Ellutia, designed to selectively remove nitrites from a extraction of a pharmaceutical product. This specialized cartridge is capable of preventing nitrites from passing through while allowing nitrosamines to do so, thereby allowing the operator to determine if the result was derived from nitrosamines or nitrite. Experimental analyses have shown that the SPE Cartridge successfully removing nitrites without impeding nitrosamine detection.
With the ATNA, pharmaceutical companies now have a tool that can detect the presence of nitrites and nitrosamines. More importantly, this detection occurs before these nitrites can potentially form nitrosamines, a significant step forward in risk mitigation.
This rapid screening approach will allow the analytical chemists to focus their attention on samples that have shown to give a positive result, rather than tying up expensive equipment and operators running samples that are potentially blank.
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